Canadian Biomarker Integration Network for Depression Study (CAN-BIND-1)

May 4, 2018 updated by: Sidney Kennedy, University Health Network, Toronto

Integrated Biological Markers for the Prediction of Treatment Response in Depression

This study is a pilot to assess feasibility of the protocol in patients and controls across six participating sites. The goal is to identify biological markers (biomarkers)that can be measured at baseline or early in treatment to predict treatment outcome in individual patients with Major Depressive Disorder (MDD). Biomarkers of interest will be clinical (using interview and self-report measures), molecular (from blood samples) and neurobiological (using neuroimaging and EEG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a study to collect clinical and biomarker data which will be used to build models to predict treatment response. This is not a study to evaluate efficacy of medications, as medications in this study have been approved by Health Canada and are widely used for the treatment of MDD.

This is an open label study involving MDD patients and healthy controls.Patients with a diagnosis of MDD and a current major depressive episode (MDE) will receive open-label standard of care treatment with escitalopram (10-20mg). Healthy controls will not receive medication; however, they will go through clinical assessments, blood collection and neuroimaging procedures.

At week 8, patients will be assessed for medication response (response is defined as ≥ 50% reduction in MADRS scores from baseline). Responders will continue medication at their effective dose until study endpoint while non-responders will receive open label add-on treatment with aripiprazole (2-10mg).

There are approximately 7 clinic visits over a 16 week period during which patients and healthy controls will undergo clinician administered scales and self reports, provide blood and urine samples (which will undergo proteomic and genomic analyses) as well as neuroimaging (fMRI and EEG).

At the end of the study, mathematical modeling methods will be used to integrate the data from the various modalities to see which features best predict treatment outcome.

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2A1
        • University of British Columbia
    • Ontario
      • Hamilton, Ontario, Canada, L8P 3B6
        • McMaster University
      • Kingston, Ontario, Canada, K7L 4X3
        • Queen's University
      • Toronto, Ontario, Canada, M5T 1R8
        • Centre for Addiction and Mental Health
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For Depressed patients:

Inclusion Criteria:

  • Outpatients who are 18-60 years of age
  • Meet DSM-IV-TR criteria for Major Depressive Episode in Major Depressive Disorder by the MINI
  • Episode duration ≥ 3 months
  • Free of psychotropic medications for at least 5 half-lives (i.e. 1 week for most antidepressants, 5 weeks for fluoxetine) before baseline Visit 1
  • MADRS ≥ 24
  • Fluency in English, sufficient to complete the interviews and self-report questionnaires

Exclusion Criteria:

  • Any Axis I diagnosis other than MDD that is considered the primary diagnosis
  • Bipolar I or Bipolar II diagnosis
  • Presence of a significant Axis II diagnosis (borderline, antisocial)
  • High suicidal risk, defined by clinician judgment
  • Substance dependence/abuse in the past 6 months
  • Presence of significant neurological disorders, head trauma or other unstable medical conditions
  • Pregnant or breastfeeding
  • Failure of 3 or more adequate pharmacologic interventions (as determined by the Antidepressant Treatment History Form)
  • Started psychological treatment within the past 3 months with the intent of continuing treatment
  • Patients who have previously failed escitalopram or showed intolerance to escitalopram and patients at risk for hypomanic switch (i.e. with a history of antidepressant hypomania)

Inclusion criteria for Healthy Controls:

  • 18 to 60 years of age
  • No history of Axis I or Axis II disorders, as determined by the MINI.
  • Fluency in English, sufficient to complete the interviews and self-report questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: escitalopram (10-20mg)
Patients are on escitalopram for 8 weeks. At Week 8, patients will be assessed as 'responders' or 'non-responders'. 'Responders' will continue on escitalopram until study endpoint.
Drug: escitalopram
Patients will be given escitalopram for the first 8 weeks of the trial. At week 8, patients who are assessed as 'responders' will continue on escitalopram until study endpoint.
Other Names:
  • Cipralex
Active Comparator: aripiprazole (2-10mg)
At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.
Drug: escitalopram
Patients will be given escitalopram for the first 8 weeks of the trial. At week 8, patients who are assessed as 'responders' will continue on escitalopram until study endpoint.
Other Names:
  • Cipralex
Drug: aripiprazole
At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.
Other Names:
  • Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline
Time Frame: Week 8, Week 16
Clinical response (≥ 50% reduction in MADRS scores from baseline)
Week 8, Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

University of British Columbia
McGill University
Centre for Addiction and Mental Health
McMaster University
University of Toronto
University of Calgary
Queen's University

Investigators

  • Principal Investigator: Sidney Kennedy, MD, University Health Network, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2012

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

July 27, 2012

First Submitted That Met QC Criteria

August 1, 2012

First Posted (Estimate)

August 2, 2012

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-0917-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

This study is funded by the Ontario Brain Institute (OBI). Data collected from this study is entered into a research database called "Brain-CODE", deployed at a High Performance Computer Virtual Lab (HPCVL). The HPCVL supports the regulatory-compliant (e.g. 21 CRF Part 11, HIPPA, PIPEDA) processes for securing privacy of healthcare data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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